Quality Compliance Coordinator
Pfizer
Cairo, Egypt
منذ 6 يوم
source : PostJobFree

Job Title : Quality Compliance Coordinator

Reports to : Site Quality Compliance Manager

location : Cairo, Egypt

Cairo, Egypt

Affiliate / Department / Location

Position summary : describe in one or two sentences the primary purpose of the job

  • Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Pfizer standards.
  • Ensure that appropriate systems are in place to meet or exceed the requirements of the company, ISO and the regulatory authorities for the quality of the products manufactured on site.
  • Responsible for Cleaning validation and External Supplier audits.
  • Job Description and tasks :

  • Share in the preparation for and escorting of quality-related audits conducted by Corporate and regulatory agencies.
  • Draft responses to audit observations.
  • Review Test Notes (Certificate of Analysis) for MOH.
  • Interface with MOH inspector to discuss lot records, manufacturing procedures, test results, and labeling.
  • Managing Supplier external audit program by setting Annual Plan, follow up its execution, reporting and action completion.
  • Participate in Site Self Audit program as a lead auditor.
  • Oversee regulatory commitments and Health Authority queries.
  • Managing & Execution of Cleaning validation plans through developing of relevant validation master plans and SOPs and Reviewing of validation protocols and reports.
  • Assessing emerging regulatory expectations and impact of inspections at other sites.
  • Site inspection readiness.
  • Quality Systems (e.g. oversight of CAS reports and PQS implementation).
  • Change control review to ensure that proposed changes are complying with PQS requirements.
  • Develop Data Integrity Plan and deployment of the plan per committed timelines.
  • Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.
  • Should perform unannounced data integrity surveillance audits.
  • Should participate in the investigation and corrective action for reported improper practice.
  • Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.
  • Provide feedback to management on periodic basis in relation to overall compliance on data integrity.
  • Shall give awareness training on reported observations, share industry insights.
  • Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
  • Active implementation of Notification to Management procedures.
  • Responsibility for compliance with Pfizer Quality Standards.
  • Experience and Knowledge

    Bachelor's degree in science / pharmaceutical sciences.

    Minimum 2 years of experience in quality assurance or compliance department.

    Essential Personal Qualifications

  • Good command of English both written and spoken.
  • Knowledgeable with interpersonal learning.
  • Good Communication skills.
  • High Precision and Accuracy.
  • Decision making skills.
  • High analytical skills.
  • Preferred Qualifications

  • Six Sigma (Green / Black belt) is a plus.
  • Knowledgeable of Pfizer / regulatory quality Standards
  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

    Quality Assurance and Control

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